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Skills

  • Research SOPs understanding
  • Problem resolution
  • Knowledge of FDA regulations
  • Patient recruitment strategies
  • Specimen collections
  • Regulatory submissions and ethics approvals
  • Compliance with Good Clinical Practice (GCP)
  • Performance metric monitoring and improvement
  • Feasibility assessments for clinical trials
  • Budget management for clinical studies

Work Experiences

  • Assisted in the creation of trial-specific documentation.
  • Administered detailed site budgets.
  • Ensured that all protocols pertaining to patient care and clinical trial operations were followed.
  • Achieved over 46% adherence to protocol.
  • Administered detailed site budgets and financial transactions, ensuring full compliance with sponsor agreements and saving $12 in discrepancies.
  • Collaborated with the principal investigator and sponsors to ensure that daily trial activities ran smoothly and that research protocols were followed.
  • Achieved a 36% reduction in time-to-resolution.
  • Achieved zero critical issues identified by external reviewers.
  • Gathered, analyzed, and modeled the data.
  • Achieved 75% enrollment within method.

Summaries

  • Achieved 78% cost efficiencies.
  • Lead Clinical Research Coordinator is a multi-talented Lead Clinical Research Coordinator who is consistently rewarded for planning and operational improvements.
  • Schedules, results, and documentation have all been coordinated in the past.
  • Recognized for motivating management team members to achieve their goals and fostering innovative work environments.
  • Achieved consistent study results across multiple research sites.
  • Achieved a 63% decrease in protocol deviations.
  • Clear understanding of process improvement and team leadership as well as client relations training.
  • During clinical research trials, adept at collecting specimens, dispensing medications, and consulting with patients.
  • Achieved a 49% improvement in study start-up times.
  • Assessed site feasibility.

Accomplishments

  • Supervised data reconciliation protocols to ensure 100% accuracy of clinical trial data and successful completion of Scrum Master audits.
  • Coordinated subject management for multi-center trials and achieved a 79% overdue visit reduction, improving patient compliance.
  • Prepared detailed reports on trial progress, leading to consistently successful audits by ITIL organizations with initiative rankings.
  • Developed forecasting models for patient recruitment, increasing precision and successfully achieving 27% over planned recruitment goals.
  • Directed the setup and monitoring of trial databases, reducing data entry errors and expediting database lock by 57%.
  • Maintained strict adherence to clinical trial milestones, promptly identifying project delays and creating corrective action plans to bring timelines back on track.
  • Standardized contract negotiation processes for site vendors, achieving a 41% reduction in incorrect invoicing and payment delays.
  • Enhanced patient follow-up process optimization by implementing Jira, which reduced lost-to-follow-up cases by 18% during the Tableau trial.
  • Designed study-specific training for staff, increasing team competency and execution speed, resulting in a 72% faster start-up time for new trials.
  • Collaborated with team of 15 in the development of process.

Affiliations

  • American Statistical Association (ASA) - Biopharmaceutical Section
  • American Society for Clinical Pharmacology and Therapeutics (ASCPT)
  • European Society of Clinical Pharmacy (ESCP)
  • National Institutes of Health (NIH) Clinical Research Group
  • Association for Clinical and Translational Science (ACTS)
  • American Marketing Association
  • Society of Women Engineers
  • Society of Human Resource Management
  • Jaycees
  • Collaborative Institutional Training Initiative (CITI Program) certification

Certifications

  • Salesforce
  • Certified Clinical Research Professional (CCRP) – Harbor & Co.
  • Association of Clinical Research Professionals (ACRP) Certification - Brightline
  • MedDRA Coding Certification - Ironclad Systems
  • Certified Clinical Research Coordinator (CCRC) - Ironclad Systems
  • Advanced GCP for Clinical Investigators - Meridian
  • Clinical Research Associate (CRA) Certification - Harbor & Co.
  • Certificate in Electronic Data Capture (EDC) Systems - metric
  • Clinical Study Feasibility and Budgeting Certification - Summit Group
  • Certified Business Analysis Professional (CBAP)

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